Echocardiographic Prediction of Fluid Responsiveness Afte... | NCT01590511

Studies
Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

NCT01590511

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Dec 4, 2015Estimated

Enrollment

71Actual

Phase

Not provided

Conditions

Shock
Circulatory Failure

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A00500-43	Other Identifier	RCB number

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Apr 30, 2012

First Submission Date that Met QC Criteria

May 2, 2012

First Posted Date

May 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2015

Last Update Posted Date

Dec 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.

Detailed Description

The secondary objectives of this study include:

To determine the sensitivity and specificity of the variation of the velocity time integral after administration of 100 cc of normal saline over 1 minute (ΔITV100) to predict the response to the filling.
To study the inter-observer variation of ΔITV100 measurement.
To compare ΔITV100 to other clinical and radiological parameters for predicting response to filling (initial value of the subaortic velocity time integral, variation in mitral E wave, E / A, respiratory variation of the diameter of the inferior vena cava, marbling clinical evolution score.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Label	Type	Description	Intervention Names
The study population		Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)		baseline; 26 minutes

Secondary Outcomes

Measure	Description	Time Frame
Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)		baseline; 15 minutes
Change in heart rate after the "mini-fluid challenge"	(bpm,%)	baseline; 26 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
Systolic blood pressure (SBP) < 90 mmHg
Signs of inadequate cardiac output: urine output <0.5 ml / kg / h for more than two hours, hyperlactataemia
Requires amines to maintain an SBP ≥ 90 mmHg or inability to lower amines or requires an increase in amines

Exclusion Criteria:

The patient is participating in another study
The patient is in an exclusion period determined by a previous study
The patient is under judicial protection, under tutorship or curatorship
The patient (or his/her person-of-trust) refuses to sign the consent
It is impossible to correctly inform the patient
The patient is pregnant, parturient, or breastfeeding
The patients has a contraindication for a treatment necessary for this study
Cardiogenic shock
Acute pulmonary edema
Moribund patient
Non echogenic patient
Patient with cardiac arrhythmia
Patients for whom the passive leg raising test is contraindicated (hyper intra-abdominal pressure, pelvic or lower limb trauma)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.

Sampling Method

Non-Probability Sample

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms